Regulatory Affairs Manager

Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager
Contract Type: Permanent
Location: Los Angeles
Job Published: October 22, 2020 16:35

Job Description

Regulatory Affairs Manager - Los Angeles/San Jose


I am currently searching for a Regulatory Affairs Manager that would be based in Los Angeles. 


The Regulatory Affairs CMC Manager would give regulatory CMC advice, including evaluating and approaches of world-wide CMC regulations and guidelines, to facilitate the progress of products from clinical trials through to global submission and approval. Duties include supporting the Regulatory CMC function in giving strategic and timely input to inquiries and problems raised by the health authorities, as well as communicating with the FDA from the development phases and post-approval (e.g. face-to-face meetings, briefing documents, contact reports, and teleconferences)


This position offers a choice to work either in Los Angeles or San Jose.


To be considered as a Regulatory Affairs Manager you must have the following:


- 2-5 years minimum of experience within Regulatory Affairs

- BA/BS or equivalent transferrable experience in a Biotechnology or Pharmaceutical company

- CMC experience

- Document Management System experience, ideally Veeva Vault or Documentum




- Proficient in CMC regulatory requirements (FDA, ICH, EMEA, etc...)



If you are interested, please apply asap.


Regulatory Affairs Manager - Los Angeles